臨床研究等提出・公開システム

Date of registration	Mar. 31, 2026
Last modified on	Mar. 31, 2026
Trial ID	jRCT2071250154

Scientific Title	A phase I clinical trial of KSP-0576
Public Title	A phase I clinical trial of KSP-0576

Contact for Scientific Queries	Name	Shimizu Yoshitaka
	Affiliation	Kissei Pharmaceutical Co., Ltd.
	Address	3-1-3, Koishikawa, Bunkyo-Ku, Tokyo, 112 0002, Japan
	Telephone	+81-3-5684-3533
	E-mail	rinsyousiken@pharm.kissei.co.jp
Contact for Public Queries	Name	Shimizu Yoshitaka
	Affiliation	Kissei Pharmaceutical Co., Ltd.
	Address	3-1-3, Koishikawa, Bunkyo-Ku, Tokyo, 112 0002, Japan
	Telephone	+81-3-5684-3533
	E-mail	rinsyousiken@pharm.kissei.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 01, 2026
Target sample size		256
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- At the time of informed consent, male aged >=18 and =<45 years or females aged >=50 and <65 years at least 12 months after the last menstrual period. - Japanese participants with a BMI >=18.5 to <25 kg/m^2 or Caucasian participants with a BMI >=18.5 to <30 kg/m^2. - Males who body weight >=50 to <90 kg and females who body weight >=45 to <90 kg.
	Exclusion Criteria	- Participants with abnormal findings on medical examination, vital signs, or 12-lead ECG, judged by the principal investigator or subinvestigator to be clinically significant.
	Age Minimum	18age old over
	Age Maximum	65age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		interstitial cystitis/bladder pain syndrome
Intervention(s)		KSP-0576 suspension will be administered orally to participants in single or multiple doses.
Primary Outcome(s)		- Incidence of adverse events and adverse drug reactions - Concentrations and pharmacokinetic parameters of KSP-0576
Secondary Outcome(s)		- Ratio of pharmacokinetic parameters of KSP 0576

Primary Sponsor	Kissei Pharmaceutical Co., Ltd.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Hakata clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka, Fukuoka, Fukuoka
Telephone	+81-92-283-7701
Approval Status	Approval
Date of approval	Mar. 26, 2026

Plan to share IPD	Yes
Plan description	- The Individual Patient Data (IPD) are available upon reasonable request and with permission of Kissei Pharmaceutical Co., Ltd. - For a data sharing request for IPD, please contact Kissei Pharmaceutical at rinsyousiken@pharm.kissei.co.jp.

Countries of Recruitment（Except Japan）	none